Leina-Werke GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000005358 FEI 3005632276
- Devices
- 14
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Leina-Werke GmbH makes
Leina-Werke GmbH manufactures elastic adhesive bandages (Fixierbinde elastisch) compliant with DIN 61634-FB specifications, sized 8 cm × 4 m.
The product is classified as Class I and registered in the EU’s eudamed database. The company is based in Germany.
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- DE-MF-000005358
- FDA FEI number
- 3005632276
- EU VAT number
- DE206633668
- EUDAMED status
- Active
- EUDAMED registered name
- Leina-Werke GmbH
- Registered address
- 1, Maueler Feld, 51570, Windeck, Germany
- Website
- www.leina-werke.de
- [email protected]
- Phone
- +49 2292 91440
- PRRC contact
- Philipp Stockmann
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Jan 2029
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1007442-1 Active
Quality management system EU MDR
- Issued
- 17 Jan 2024
- Expires
- 16 Jan 2029
Frequently asked questions
How many devices does Leina-Werke GmbH have in the registry?
The registry currently lists 14 devices for Leina-Werke GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Leina-Werke GmbH's devices?
Among its 14 most recently registered devices, Leina-Werke GmbH has devices listed in EUDAMED (14 devices).
What risk classes do Leina-Werke GmbH's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Leina-Werke GmbH's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Leina-Werke GmbH?
EUDAMED lists 1 certificate for Leina-Werke GmbH (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 17 Jan 2024.
What are the newest devices from Leina-Werke GmbH in the registry?
The most recently registered devices listed for Leina-Werke GmbH include Verbandpäckchen DIN 13151-G, Verbandpäckchen DIN 13151-K, Verbandtuch DIN 13152-A and Flawa Verbandpatrone DIN 13151-M.